VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

• Sponsor: Venatorx Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04877379
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 53
• Location: 1
• Arms: 6
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 10.4

Study Details

Study Description

Brief Summary

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten); Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Part 1: Crossover Parts 2&3: ParallelPart 1: Crossover Parts 2&3: Parallel
• Masking: Double (Participant, Investigator)
• Masking Description: Part 1: Unblinded Parts 2&3: Blinded
• Primary Purpose: Basic Science
• Official Title: VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
• Actual Study Start Date: Jun 8, 2021
• Actual Primary Completion Date: Nov 10, 2021
• Actual Study Completion Date: Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1 Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Experimental: Part 2A Multiple dose administration of VNRX-7145 q8h for 10 days	Drug: VNRX-7145; β-lactamase inhibitor
Placebo Comparator: Part 2B Multiple dose administration of placebo q8h for 10 days	Drug: Placebo; Placebo
Experimental: Part 3A Multiple dose administration of low dose VNRX-7145 + VNRX-5024	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Experimental: Part 3B Multiple dose administration of high dose VNRX-7145 + VNRX-5024	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Placebo Comparator: Part 3C Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)	Drug: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Part 1: Cmax [0-48 hours]

   concentration time data

2. Part 1: AUC0-inf [0-48 hours]

   Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK

3. Parts 2&3: Number of subjects with adverse events [Day 15 (+2)]

Secondary Outcome Measures

1. Part 1: Number of subjects with adverse events [Day 14 (+2)]

2. Parts 2&3: AUC0-tau [Day 1]

3. Parts 2&3: AUC0-tau [Day 10]

4. Parts 2&3: Cmax [Day 1]

5. Parts 2&3: Cmax [Day 10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy adults 18-55 years

2. Males or non-pregnant, non-lactating females

3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2

4. Normal blood pressure

5. Normal lab tests

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders

2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug

3. Use of antacid medications

4. Abnormal ECG or history of clinically significant abnormal rhythm disorder

5. Positive alcohol, drug, or tobacco use/test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences - Early Development Services	Groningen		Netherlands

Sponsors and Collaborators

• Venatorx Pharmaceuticals, Inc.
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Venatorx Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04877379
• Other Study ID Numbers: VNRX-7145-102; 272201600029C-P00007-9999-2
• First Posted: May 7, 2021
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ceftibuten

Study Results

No Results Posted as of Jun 15, 2022